Thursday, 17 October 2013

The Advisory Committee voted against
recommending ANCHOR approval by a margin of nine to two. Joseph S. Zakrzewski,
CEO said, ‘It's frustrating to have a number of panel members express that the
company did everything that’s been asked of it for negotiating SPAs yet still
not receive a positive vote for approval’.

The company conducted a successful
MARINE study, a successful ANCHOR study, successfully enrolled the REDUCE-IT
trial to over 6,000 patients and has a product that everyone ultimately agreed
was safe. The company still continues to believe that a fair read of all the
available data including available outcome studies reflect positively on
Vascepa, the ANCHOR indication and the anticipated results of the upcoming
REDUCE-IT study.

The FDA is scheduled to make its
decision on whether to approve the ANCHOR supplemental sNDA by December 20,
2013; that's the PDUFA date, the company’s goal date for the application.

Recommendations provided by the Advisory
Committee will be considered by the FDA in its review but the FDA is not bound
to follow them in determining whether they will approve an application. ‘Having
said that, we do recognize, given today's panel, that this is an uphill battle’
said Mr. Zakrzewski.

As expected, based on the FDA’s briefing
materials there was very robust discussion in the meeting surrounding the efficacy
and safety of Vascepa and the desire for the improvement of cardiovascular
outcomes in treating patients with mixed dyslipidemia, but it wasn’t enough to
win the day.